Regulations

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EPA is committed to considering risks to children in developing standards to protect human health and the environment. This commitment is reflected in:

Rulemaking Guidance

EPA has developed a regulatory action development guidance entitled Guide to Considering Children's Health When Developing EPA Actions: Implementing Executive Order 13045 and EPA's Policy on Evaluating Health Risks to Children. This Guide is designed to help Agency staff involved in developing regulatory actions determine whether Executive Order 13045 Protection of Children from Environmental Health Risks and Safety Risks and/or EPA's Policy on Evaluating Health Risks to Children (Children's Health Policy) applies to an Agency action and, if so, how to implement the Executive Order and/or EPA's Policy. EO 13045 requires that each Federal agency: "(a) shall make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children; and (b) shall ensure that its policies, programs, activities, and standards address disproportionate risks to children that result from environmental health risks or safety risks." In addition, the Children's Health Policy requires EPA "to consider the risks to infants and children consistently and explicitly as a part of risk assessments generated during its decision making process, including the setting of standards to protect public health and the environment." Since the issuance of the first EPA's Rule Writer's Guide to Executive Order 13045 in 1998, EPA has published several guidance documents relating to risk assessment, regulatory policy and action development. The Guide has been revised to reflect these developments. In addition, this Guide more clearly integrates EPA's Policy on Children's Health with the Action Development Process, and provides an updated listing of additional guidance documents.

EPA typically prepares an Analytic Blueprint when developing rules, policies, and other actions. An Analytic Blueprint describes the Agency's plans for data collection and analyses to support developing the action. To ensure that children's health is properly considered, the Guidelines identify the need for analyses related to children's health including determining whether the action may disproportionately affect children, assessing risks to children, and analyzing the distribution of the costs and benefits. For more information on how EPA writes regulations and the EPA regulatory management process, see The Basics of the Regulatory Process.

EPA developed a Children's Health Valuation Handbook (October 2003) as a reference tool for analysts conducting economic analyses of EPA regulations and policies that may affect risks to children's health. This handbook focuses on valuing changes in risks to children's health caused by environmental improvement or degradation. It addresses incorporating children's health considerations in efficiency assessments and distributional analyses.

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Transparency in Regulatory Development

On April 14, 2008, EPA announced that it is making Federal environmental regulation more transparent by providing online information as soon as the agency begins the development of a new rule.

EPA is now using Action Initiation Lists (AILs) to notify the public about new rules and other regulatory actions. The AILs provide summaries, agency contacts, and other information about the rules EPA has approved for development. AILs will be posted on the EPA Web site at roughly the end of each month; each will describe those actions that were approved for commencement during the given month. Formerly, the public had to wait for EPA's Semiannual Regulatory Agenda, which is updated only every six months, to learn about new regulatory actions. Learn more about EPA's Action Initiation Lists.

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Development of Rules and Actions

Background

Regulatory Actions are one of the major ways that EPA can protect children from environmental health hazards. Executive Order 13045, signed in 1997 by President Clinton, directs the EPA and other federal agencies to “make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children” and “ensure that its policies, programs, activities, and standards address disproportionate risks to children that result from environmental health risks or safety risks”. Therefore, under this directive, the EPA considers potential impacts for adverse effects on children in its rulemakings. Children have many unique susceptibilities to environmental contaminants. Because of differences in breathing patterns, food and water consumption, activity patterns, and inherent physiological and developmental differences depending on life stage, children may experience greater health effects from environmental risks than adults.

Breathing: Children breathe more than adults (per pound body weight and surface area of the respiratory tract). For example, a three month old infant breathes about 35 times more air than adults. Additionally, substantial lung development takes place after birth, primarily through adolescence.

Eating and drinking: Children consume more food and water than adults (per pound body weight). Young children often have higher intakes of certain food categories, and are more likely to have less variation in their diets. For example, infants consume approximately ten times more apples than adults. Breast milk is another important exposure pathway that is unique to infants and young children. Additionally, infants may consume a large volume of drinking water through infant formula that is reconstituted with tap water.

Activity patterns: Children are more likely to spend time outdoors than adults and are therefore more likely to be exposed to certain outdoor pollutants. Also, infants and toddlers are disproportionately exposed to many contaminants because they crawl and play on or near the floor or ground. Contaminants, such as lead and pesticides, often settle in floor dust where children can be exposed to them. Infants and toddlers also pass through a developmental stage characterized by oral exploration. They often touch or handle objects and then place their fingers or the objects into their mouths. As a result of this mouthing behavior, children can consume much higher levels of contaminated dirt and dust than adults.

Physiological differences: There are many physiological differences that can affect how environmental contaminants are absorbed, distributed, metabolized, and excreted from a child’s body. For example, children’s skin is more permeable and easily damaged. Children also retain ingested substances longer in the stomach and the small intestines, they have a more permeable blood-brain barrier, and they have greater cerebral blood flow.

Developmental differences: A child undergoes critical stages of development for each organ and system, where there is the potential for chemical exposures to disrupt growth patterns. For example, the nervous, reproductive and metabolic systems develop throughout childhood, and the respiratory system is fully developed between two and ten years of age, with growth continuing through adulthood.

The Office of Children’s Health Protection’s (OCHP) Regulatory Support and Science Policy Division (RSSPD) works to address the potential for unique exposures, hazards, health effects, and health risks in children during the development of agency regulations and policies. This page provides examples of some of the important regulations EPA is currently working on that are of interest to children’s health. A link for more information is included after each description.

Air Regulations

Review of the National Ambient Air Quality Standards for Nitrogen Dioxide
Research has shown that exposures to nitrogen dioxide, a reactive gas common in automobile emissions, are linked with a variety of respiratory effects, including respiratory symptoms in children, particularly those with asthma.  Infants and children may be more susceptible than adults because their lungs are still developing, they have greater prevalence of asthma, they have higher breathing rates per body weight, and participate in higher exposure activities, including outdoor play.  For more information, see: 


http://www.epa.gov/ttn/naaqs/standards/nox/s_nox_index.html

Review of the National Ambient Air Quality Standards for Sulfur Dioxide
Current scientific evidence links short-term exposures to sulfur dioxide (SO2), a reactive gas created from fossil fuel combustion, with an array of adverse respiratory effects including bronchoconstriction and increased asthma symptoms.  These effects are particularly important for children and adults with asthma while at elevated ventilation rates (e.g., while exercising or playing).  Studies also show a connection between short-term exposure and increased visits to emergency departments and hospital admissions for respiratory illnesses, particularly in at-risk life stages such as children.  For more information, see:


http://www.epa.gov/ttn/naaqs/standards/so2/s_so2_index.html

Review of the National Ambient Air Quality Standards for Lead
Lead harms the nervous systems of infants and children, affecting IQ, learning abilities, and behavioral problems. Lead exposure also impairs normal growth and harms the immune and other systems. Lead emitted into the air can be inhaled and lead that has settled onto surfaces (e.g. in dust) can be ingested, the latter of which is the main route of exposure to lead in ambient air.  At the national level, major sources of lead in the air are ore and metals processing and piston-engine aircraft operating on leaded aviation fuel.  Other sources include waste incinerators, utilities, and lead-acid battery manufacturers.  Children are most vulnerable to the damaging effects of lead because they not only breathe lead in ambient air but are also more likely to ingest lead during hand-to-mouth activity, and their bodies are still developing rapidly.  For more information, see:

http://www.epa.gov/ttn/naaqs/standards/pb/s_pb_index.htm

Review of the National Ambient Air Quality Standards for Particulate Matter

Although the review of the Particulate Matter (PM) National Ambient Air Quality Standard kicked off in early 2015, the effort is still in its early stages.  EPA will be conducting quantitative analyses of PM exposures and risks and, as appropriate, will prepare a risk and exposure assessment document (REA) presenting and assessing these analyses.  The rule is likely to address the adverse impacts of exposure on prenatal and childhood lifestages.  The potential adverse impacts are expected to be due to increased exposure (i.e., children and/or women of childbearing age are more likely to be highly exposed than other lifestages).  For more information, see: 

https://www3.epa.gov/ttn/naaqs/standards/pm/s_pm_index.html.

Endangerment Finding for Lead Emissions from Piston-Engine Aircraft Using Leaded Aviation Gasoline

Although removed from automobile gasoline by 1996, lead is still used in aviation gasoline for piston-engine powered aircraft and currently accounts for approximately half the lead emitted to air in the U.S. annually. EPA is evaluating lead emissions, ambient concentrations and potential exposure to lead from the use of leaded aviation gasoline in piston-engine powered aircraft. Lead harms the nervous systems of infants and children, affecting IQ, learning abilities, and behavioral problems. Lead exposure also impairs normal growth and the harms the immune and other systems.


http://www.epa.gov/otaq/regs/nonroad/aviation/420f10013.pdf

Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles

Although removed from automobile gasoline by 1996, lead is still used in aviation gasoline for piston-engine powered aircraft and currently accounts for approximately half the lead emitted to air in the U.S. annually. EPA is evaluating lead emissions, ambient concentrations and potential exposure to lead from the use of leaded aviation gasoline in piston-engine powered aircraft. Lead harms the nervous systems of infants and children, affecting IQ, learning abilities, and behavioral problems. Lead exposure also impairs normal growth and harms the immune and other systems.

http://www.epa.gov/otaq/climate/regs-heavy-duty.htm

Greenhouse Gas Emissions Standards for Light-Duty Vehicles
The changes in temperature, precipitation, sea level, and weather patterns now taking place because greenhouse gas, or carbon, emissions are likely to have unique effects on the health of children. Children, particularly young children, are more vulnerable than others to heat waves, extreme weather events, declining air quality, and climate-sensitive diseases, and therefore will see more impacts due to climate change. In 2013, light-duty cars and trucks accounted for 16% of all carbon emissions in the U.S., and 60% of carbon emissions for the transportation sector, by far the largest contributing category for this sector. EPA’s program to reduce carbon emissions from light-duty vehicles is expected to cut 6 billion metric tons of carbon emission over the lifetime of vehicles sold in model years 2021-2025. Reducing light-duty carbon emissions may help reduce the severity or likelihood of the impacts of climate change. 

https://www3.epa.gov/otaq/climate/regs-light-duty.htm

Water Regulations

National Primary Drinking Water Regulations for Lead and Copper: Regulatory Revisions
Lead and copper leach from plumbing materials, so children can be exposed through drinking water. Short-term copper exposure may cause health problems such as gastrointestinal distress, and long-term exposure may lead to liver or kidney damage. Lead harms the nervous systems of infants and children, affecting IQ, learning abilities, and behavioral problems. Lead exposure also impairs normal growth and harms the immune and other systems. Drinking water contaminated with lead and copper is particularly concerning for children because they absorb lead and copper in the digestive tract at higher rates than adults and consume more water than adults, especially infants whose formula is made with tap water.


http://yosemite.epa.gov/opei/rulegate.nsf/byRIN/2040-AF15?opendocument

National Primary Drinking Water Regulations: Regulation of Perchlorate
EPA has initiated the process to develop a national primary drinking water regulation (NPDWR) for perchlorate. An NPDWR will establish a legal limit on the level of perchlorate in drinking water to reflect both the level that protects human health and the level that water systems can achieve using the best available technology. The National Academy of Sciences identified "the fetuses of pregnant women who might have hypothyroidism or iodide deficiency" as "most sensitive" but also identified infants and developing children as additional “sensitive” lifestages. Infants and young children have greater exposure to contaminants in food and water because they consume more food and water as a proportion of body weight, especially infants whose formula is made with tap water. These lifestages may be the most vulnerable because of relative exposure. EPA has collaborated with Food and Drug Administration scientists to develop a Biologically Based Dose Response (BBDR) model that can integrate available health related information to assess the effects of perchlorate on thyroid hormone production. EPA will hold a peer review in the second half of 2016 of the draft BBDR model and how EPA intends to use model results to develop a perchlorate maximum contaminant level goal.


http: //water.epa.gov/drink/contaminants/unregulated/perchlorate.cfm

National Primary Drinking Water Regulations: Group Regulations of Carcinogenic Volatile Organic Compounds (VOCs)

Early-life exposure to carcinogenic volatile organic compounds (VOCs) may increase the risk of developing cancer later in life. Carcinogenic VOCs in drinking water are a particular concern for children because they consume more water than adults per unit body weight, especially infants whose formula is reconstituted with tap water. Exposures to certain carcinogenic VOCs may also lead to other adverse noncancer health effects such as reproductive and developmental effects. In addition, the 2005 Cancer Guidelines require consideration related to increased risks from mutagenic carcinogens due to early childhood exposure.

http://yosemite.epa.gov/opei/rulegate.nsf/byRIN/2040-AF29

Drinking Water Contaminant Candidate List 4

The Contaminant Candidate List (CCL) is a list of contaminants that are currently not subject to any proposed or promulgated national primary drinking water regulations, but are known or anticipated to occur in public water systems. Contaminants listed on the CCL may be of importance to children’s health and may require future regulation under the Safe Drinking Water Act (SDWA). The Draft CCL 4 includes 100 chemicals or chemical groups and 12 microbial contaminants. The list includes, among others, chemicals used in commerce, pesticides, biological toxins, disinfection byproducts, pharmaceuticals and waterborne pathogens. In 2015, EPA requested public comments on the chemical and microbial contaminants included in the Draft CCL 4 and on improvements to the CCL selection process to be considered for future CCLs.

http://www2.epa.gov/ccl/draft-contaminant-candidate-list-4-ccl-4

Third Six-Year Review of Existing National Primary Drinking Water Regulations

The Safe Drinking Water Act (SDWA) requires EPA to review each national primary drinking water regulation at least once every six years and revise them, if appropriate. As part of the "Six-Year Review," EPA evaluates any newly available data, information and technologies to determine if any regulatory revisions are needed. Revisions must maintain or strengthen public health protection. Drinking water contaminants may have adverse health effects associated with exposures for a specific developmental group or period of sensitivity. Drinking water contaminants are a concern for children because they consume more water than adults, especially infants whose formula is made with tap water.

http://www.epa.gov/dwsixyearreview

Unregulated Contaminant Monitoring Rule

EPA uses the Unregulated Contaminant Monitoring Rule (UCMR) to collect data on contaminants suspected to be present in drinking water but that do not have health-based standards under the Safe Drinking Water Act (SDWA). Every five years, EPA revises the list of contaminants based on the Contaminant Candidate List and collects occurrence data on the new list. Exposure to contaminants may have adverse health effects associated with a specific developmental group or period of sensitivity. Contaminants are a concern for children because they consume more water than adults do, especially infants whose formula is made with tap water.

https://www.epa.gov/dwucmr

Chemical Safety Regulations

Lead; Renovation, Repair, and Painting Program for Public and Commercial Buildings
Lead harms the nervous systems of infants and children, affecting IQ, learning abilities, and behavioral problems. Lead exposure also impairs normal growth and harms the immune and other systems. Common renovation activities on public and commercial buildings may deposit lead dust and paint chips on interior surfaces and nearby properties, such as housing and day care centers. This may expose children both inside and outside of such facilities to lead-based paint dust. Children may also accidentally ingest lead dust and paint chips through common hand-to-mouth behavior.


http://yosemite.epa.gov/opei/RuleGate.nsf/byRIN/2070-AJ56

Lead Wheel Weights; Regulatory Investigation
Lead harms the nervous systems of infants and children, affecting IQ, learning abilities, and behavioral problems. Lead exposure also impairs normal growth and harms the immune and other systems. Lead wheel weights are sometimes lost in the environment where children can be exposed.


http://yosemite.epa.gov/opei/rulegate.nsf/byRIN/2070-AJ64

Lead; Residential Lead Dust Hazard Standards (TSCA Sec 403)
Many products found in and around our homes used lead for years, and some still do. Older homes may have lead-based paint, which creates lead paint chips and dust. Lead harms the nervous systems of infants and children, affecting IQ, learning abilities, and behavioral problems. Lead exposure also impairs normal growth and harms the immune and other systems. Infants and children may put their hands and other objects that have lead dust on them into their mouths, increasing their exposure. Children’s growing bodies also absorb more lead than adult bodies do, and their brains and nervous systems are more sensitive to the damaging effects of lead.

https://yosemite.epa.gov/opei/rulegate.nsf/byRIN/2070-AJ82
http://www2.epa.gov/lead/hazard-standards-lead-paint-dust-and-soil-ts ca-section-403

Polychlorinated Biphenyls (PCBs); Reassessment of Use Authorizations
Exposure to PCBs during pregnancy and childhood is of great concern because the effects of PCBs on sensitive immature tissues, organs, and systems can have serious and long-lasting consequences. PCBs have been linked to various health outcomes, such as decreased gestational age at birth, lower birth weight, depressed immune responses, impaired mental development, and growth retardation. Although background levels of PCBs in the population have declined over the past few decades, nursing infants may have especially high exposures as PCBs are lipophilic substances that can accumulate in breast milk.

Polychlorinated Biphenyls (PCBs): https://www.epa.gov/pcbs
Reassessment of Use Authorizations for PCBs in Small Capacitors: https://yosemite.epa.gov/opei/RuleGate.nsf/byRIN/2070-AK12
Reassessment of PCB Use Authorizations: http://yosemite.epa.gov/opei/rulegate.nsf/byRIN/2070-AJ38

Pesticides; Certification and Training Revision

The EPA expects to release stronger training and certification standards for pesticide applicators who are certified to apply the riskiest pesticides, known as restricted use pesticides (RUPs) by the end of 2016. The current rule was last updated in 1974. Federal regulations require applicators to be certified in order to apply RUPs. Additionally, RUPs may be used only by, or under the direct supervision of, certified applicators. The goal is to reduce the likelihood of harm from the misapplication of RUPs and ensure a consistent level of protection among states. The new rule is expected to:

  • Enhance applicator competency standards to ensure that RUPs are used safely.

  • Establish a first time-ever nation-wide minimum age of 18 for certified applicators and persons working under their direct supervision.

  • Require all applicators to renew certifications more frequently.

  • Require additional specialized certifications for people using high-risk application methods (fumigation and aerial).

  • Require safety training and increased oversight for persons working under the direction supervision of a certified applicator. Training includes reducing take-home pesticide exposure to protect worker families.

https://www.epa.gov/pesticide-worker-safety/epa-proposes-stronger-standards-people-applying-riskiest-pesticides  

Registration Review for Chlorpyrifos
Chlorpyrifos is an organophosphate (OP) pesticide with registered uses primarily on food and feed crops. Several of the limited non-agricultural and non-residential uses are for golf course turf, wood products, greenhouse and nursery production, and adult mosquitocide. In 2000, all residential uses of chlorpyrifos were cancelled except for ant and roach bait station products in child resistant packaging. Chlorpyrifos is currently undergoing registration review, which is EPA’s process pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Each registered pesticide is reviewed every 15 years to determine whether it continues to meet the FIFRA standard for registration. There is evidence that exposure to OP pesticides can affect the developing nervous system. Prenatal exposure in pregnant women and early postnatal exposure are particularly concerning because they are vulnerable periods for the developing nervous system. Behavioral patterns of young children, such as playing on the floor and putting objects in their mouths, also increase the chance of dermal or oral exposure.


2014 Revised Human Health Risk Assessment: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2008-0850-0200

2015 Proposed Tolerance Revocations: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2015-0653-0001

TSCA Section 6(a) Rulemaking on Paint Removers Methylene Chloride and N-Methylpyrrolidone (NMP)

EPA has initiated a rulemaking under Section 6(a) of the Toxic Substances Control Act (TSCA) to address the risks identified in the risk assessments of methylene chloride and NMP when used in commercial and consumer paint removers. The final risk assessment for NMP identified risks to pregnant women and women of childbearing age who have high exposure to NMP through paint or other coating removal, with possible effects of low birth weight and other developmental effects.  The paint removers risk assessments, additional risk assessments, and more information on upcoming assessments can be found at:

http://www.epa.gov/oppt/existingchemicals/pubs/riskassess.html. More information on the TSCA Work Plan for Chemical Assessments can be found at:

http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html. For more information on the paint removers rulemaking, visit: http://yosemite.epa.gov/opei/rulegate.nsf/byrin/2070-ak07.

Trichloroethylene TSCA Section 6(a) – Use in Dry Cleaning and Aerosol Degreasing

The Toxic Substances Control Act (TSCA) provides authority for EPA to ban or restrict the manufacture (including import), processing, distribution in commerce, and use of chemicals, as well as any manner or method of disposal. EPA identified trichloroethylene (TCE) for risk evaluation as part of its Work Plan for Chemical Assessment under TSCA.

TCE is used in industrial and commercial processes, and also has some limited uses in consumer products. In the June 2014 TSCA Work Plan Chemical Risk Assessment, EPA identified risks, including developmental toxicity, associated with commercial degreasing and some consumer uses. EPA is initiating rulemaking under TSCA section 6 to address these risks. Specifically, EPA will determine whether the continued use of TCE in aerosol degreasing and as a spotting agent in dry cleaning poses an unreasonable risk to human health and the environment.

http://yosemite.epa.gov/opei/RuleGate.nsf/byRIN/2070-AK03

Trichloroethylene TSCA Section 6(a) – Use in Vapor Degreasing

The Toxic Substances Control Act (TSCA) provides authority for EPA to ban or restrict the manufacture (including import), processing, distribution in commerce, and use of chemicals, as well as any manner or method of disposal. EPA identified trichloroethylene (TCE) for risk evaluation as part of its Work Plan for Chemical Assessment under TSCA.

TCE is used in industrial and commercial processes, and also has some limited uses in consumer products. In the June 2014 TSCA Work Plan Chemical Risk Assessment, EPA identified risks, including developmental toxicity, associated with commercial vapor degreasing. EPA is initiating rulemaking under TSCA section 6 to address these risks. Specifically, EPA will determine whether the continued use of TCE in commercial vapor degreasing poses an unreasonable risk to human health and the environment.

https://yosemite.epa.gov/opei/RuleGate.nsf/byRIN/2070-AK11

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